关键词: 色谱法，高压液相；对乙酰氨基酚；咖啡因；生物等效性；体内外相关性

Abstract:

Objective    To evaluate the correlation of absorption and dissolution of acetaminophen A, B, C tablets for the quality control of acetaminophen oral preparations. Methods    An HPLC method was used to determine the concentration of acetaminophen in plasma after a single dose of acetaminophen tablets in a 3cycle crossover test, and the pharmacokinetic parameters were calculated. The T50 and Td of acetaminophen tablets were obtained via dissolution test. Results     The main pharmacokinetic or dissolution parameters of acetaminophen A, B, C tablets were as follows, t1/2 as (2.41±0.51), (2.85±0.55) and (7.79±0.54)h, Tmax as (1.38±0.60), (0.98±1.00) and (0.98±0.43)h, AUC015 as (27.24±10.87), (27.64±8.01) and (26.76±0.43) μg/mL·h, AUC0∞ as (27.68±10.94), (28.36±8.16) and (7.46±7.29)μg/mL·h; T50 as (33.34±4.81), (3.33±0.38) and (2.54±0.32)min，Td  as( 41.24±4.03),(4.50 ±0.61) and(3.67±0.45)min. Conclusions    Acetaminophen A, B, C tablets from three factories with different dissolutions are bioequivalent. The dissolution and absorption are partly related.

Key words: Acetaminophen; Caffeine; Bioequivalence; In vivo-in vitro correlation; High performance liquid chromatography